BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK C DOUBLE CONTRAST BARIUM ENEMA TUBE

    MDR report key: 23954 · Received July 6, 1995

    Report

    Report Number
    23954
    Event Type
    Injury
    Date Received
    July 6, 1995
    Date of Event
    January 10, 1995
    Report Date
    January 25, 1995
    Manufacturer
    MMI
    Product Code
    FGD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED THE FOLLOWING SYMPOMS DURING AND IMMEDIATELY AFTER BARIUM ENEMA EXAMINATION: RUNNY NOSE, SNEEZING, COUGH, CHEST TIGHTNESS, ITCHING, BURNING EYES, ERYTHEMA, TINGLING AROUND MOUTH AND UPPER EXTREMITIES, NAUSEA AND VOMITING. PRODUCT PACKAGING DID NOT READILY IDENTIFY LATEX COMPONENT OF THE RETENTION CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK C DOUBLE CONTRAST BARIUM ENEMA TUBE BARIUM ENEMA TUBE FGD MMI B-305-57-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention